Devices for reducing the size of an internal tissue opening

ABSTRACT

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device to reduce out of plane bending. The closure device can also include a member adapted to induce tissue growth.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/821,947, filed

Aug. 9, 2006, U.S. Provisional Application No. 60/821,949, filed Aug. 9,2006, U.S. Provisional Application No. 60/829,507, filed Oct. 13, 2006,U.S. Provisional Application No. 60/866,047, filed Nov. 15, 2006, andU.S. Provisional Application No. 60/942,625, filed Jun. 7, 2007, thecontents of each of which are hereby incorporated by reference in theirentirety. This application relates to U.S. patent application Ser. No.11/836,016, filed Aug. 8, 2007, titled DEVICES FOR REDUCING THE SIZE OFAN INTERNAL TISSUE OPENING, U.S. patent application Ser. No. 11/836,037,filed Aug. 8, 2007, titled DEVICES FOR REDUCING THE SIZE OF AN INTERNALTISSUE OPENING, U.S. patent application Ser. No. 11/836,051, filed Aug.8, 2007, titled SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNALTISSUE OPENING, U.S. patent application Ser. No. 11/836,013, filed Aug.8, 2007, titled SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNALTISSUE OPENING, U.S. patent application Ser. No. 11/836,026, filed Aug.8, 2007, titled METHODS FOR DETERMINING CHARACTERISTICS OF AN INTERNALTISSUE OPENING, and U.S. patent application Ser. No. 11/836,123, filedAug. 8, 2007, now U.S. Pat. No. 8,167,894, titled METHODS, SYSTEMS ANDDEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING, thecontents of each of which are hereby incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to medical devices and methodsof use for treating an internal tissue structure. More particularly, thepresent invention relates to medical devices, systems, and methods forreducing the size of an internal tissue opening.

2. The Relevant Technology

Physical malformations or defects that are present at birth can bedetrimental and even lethal when left uncorrected. A PFO is an exampleof a cardiac birth defect that can be problematic and even result indeath when combined with other factors such as blood clots or othercongenital heart defects. A PFO occurs when an opening between the uppertwo chambers of the heart fail to close after birth.

Some of the problems associated with a PFO can occur when a blood clottravels from the right to the left atria of the heart through the PFO,and lodges in an artery that feeds blood to the brain. A blood clot inthe left atrium can be passed through the aorta and travel to the brainor other organs, and cause embolization, stroke, or a heart attack. APFO can be treated by being closed by a surgical procedure.Additionally, other similar defects (e.g. septal or otherwise) wheresome tissue needs to be closed in order to function properly can includethe general categories of atrial-septal defects (“ASDs”),ventricular-septal defects (“VSD's”) and patent ductus arteriosus(“PDA”), and the like.

FIGS. 1A-1C depict various views of a heart having a PFO. The heart 10is shown in a cross-section view in FIG. 1A. In a normal heart 10, theright atrium 30 receives systemic venous blood from the superior venacava 15 and the inferior vena cava 25, and then delivers the blood viathe tricuspid valve 35 to the right ventricle 60. However, in thedepicted heart 10 a septal defect, which is shown as a PFO 50, ispresent between right atrium 30 and left atrium 40.

The PFO 50 is depicted as an open flap on the septum between the heart'sright atrium 30 and left atrium 40. In a normal heart 10, the leftatrium 40 receives oxygenated blood from the lungs via pulmonary artery75, and then delivers the blood to the left ventricle 80 via the mitralvalve 45. In a heart 10 having a PFO 50 some systemic venous blood canalso pass from the right atrium 30 through the PFO 50 and mixes with theoxygenated blood in left atrium 40, and then is routed to the body fromleft ventricle 80 via aorta 85.

During fetal development of the heart 10, the interventricular septum 70divides the right ventricle 60 and left ventricle 80. In contrast, theatrium is only partially partitioned into right and left chambers duringnormal fetal development, which results in a foramen ovale fluidlyconnecting the right and left atrial chambers. As shown in FIG. 1B, whenthe septum primum 52 incompletely fuses with the septum secundum 54 ofthe atrial wall, the result can be a tunnel 58 depicted as a PFO 50.

FIG. 1C provides a view of the crescent-shaped, overhangingconfiguration of the septum secundum 54 from within the right atrium 30in a heart 10 having a PFO 50. The septum secundum 54 is defined by itsinferior aspect 55, corresponding with the solid line in FIG. 1C, andits superior aspect 53 represented by the phantom line, which is itsattachment location to the septum primum 52. The septum secundum 54 andseptum primum 52 blend together at the ends of the septum secundum 54.The anterior end 56 a and posterior end 56 p are referred to herein as“merger points” for the septum secundum 54 and septum primum 52. Thelength of the overhang of the septum secundum 54, which is the distancebetween superior aspect 53 and inferior aspect 55, increases towards thecenter portion of the septum secundum as shown.

The tunnel 58 between the right atrium 30 and left atrium 40 is definedby portions of the septum primum 52 and septum secundum 54 between themerger points 56 a and 56 p which have failed to fuse. The tunnel 58 isoften at the apex of the septum secundum 54 as shown. When viewed withinright atrium 30, the portion of the septum secundum 54 to the left oftunnel 58, which is referred to herein as the posterior portion 57 p ofthe septum secundum, is longer than the portion of the septum secundum54 to the right of tunnel 58, which is referred to herein as theanterior portion 57 a of the septum secundum 54. In addition to beingtypically longer, the posterior portion 57 p also typically has a moregradual taper than the anterior portion 57 a as shown. The anteriorpocket 59 a is the area defined by the overhang of the anterior portion57 a of the septum secundum 54 and the septum primum 52, and it extendsfrom the anterior merger point 56 a toward the tunnel 58. Similarly, theposterior pocket 59 p is the area defined by the overhang of theposterior portion 57 p of septum secundum 54 and the septum primum 52,and it extends from the posterior merger point 56 p toward the tunnel58.

Conventional treatments for PFO, and other related conditions havegenerally involved invasive surgery, which also presents a risks to apatient. Although there are some less invasive treatments for PFO, suchtreatments have been less efficient at closing the PFO opening thantechniques involving invasive surgery.

BRIEF SUMMARY OF THE INVENTION

The invention relates to a medical system, devices and methods of usefor reducing the size of an internal tissue opening, such as a PatentForamen Ovale (“PFO”). In one embodiment of the invention, the medicalsystem can include a closure device and an associated delivery device.The medical system can be configured to enable a practitioner toselectively position and deploy the closure device in an internal tissueopening to approximate, or in other words bring together the tissue ofthe opening.

According to one embodiment of the invention, the closure device caninclude a multi-cellular body portion operatively associated with afirst anchor and a second anchor. The multi-cellular body portion can beconfigured to enable the closure device to collapse into a relativelynarrow non-deployed orientation and expand into a deployed or expandedorientation without plastic deformation or failure of the closuredevice. The first and second anchors can be configured to engage atleast a portion of a wall of the internal tissue opening and/or tissue,such as tunnel tissue, of the opening. In one embodiment of theinvention, the closure device can be a non-tubular, substantially flatstent.

In one embodiment of the invention the closure device can include aningrowth material to facilitate tissue growth. The closure device canalso include one or more indicators to facilitate the estimation of theposition and/or orientation of the closure device with respect to theinternal tissue opening.

In accordance with the present invention, the delivery device caninclude a delivery assembly, an actuating assembly, and a releaseassembly operatively associated with a handle body. In one embodiment ofthe invention, the delivery assembly facilitates selective delivery ofthe closure device from the delivery device, and is operativelyassociated with the actuating assembly and the release assembly. Theactuating assembly interacts with the handle body to selectively deploythe closure device from the delivery assembly. In one embodiment of theinvention, the actuating assembly can be configured to deploy at least aportion of the closure device by a first movement and deploy a secondportion of the closure device by a second movement. The release assemblycan be linked to the handle body to facilitate detachment of the closuredevice from the delivery device.

In one embodiment, the closure device is linked to the delivery deviceby one or more tethers and one or more wires, the tethers being coupledto the handle body and the wires being coupled to a biasing member ofthe release assembly. The tethers can be configured to receive a portionof the closure device therein to facilitate securement of the closuredevice to the delivery device. The wires can be detachably coupled tothe closure device to enable selective detachment of the closure devicefrom the delivery device by movement of the biasing member.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1C illustrate exemplary views of a heart having a PatentForamen Ovale;

FIG. 2 illustrates a perspective view of an embodiment of a medicalsystem according to the present invention;

FIG. 3A illustrates an embodiment of a closure device according to thepresent invention;

FIG. 3B illustrates an embodiment of a closure device in a non-deployedorientation according to the present invention;

FIG. 3C illustrates a cut-out view of a portion of a closure deviceaccording to the present invention;

FIG. 4 illustrates an embodiment of a delivery device according to thepresent invention;

FIGS. 5A-5C illustrate cross-sectional views of a delivery deviceaccording to the present invention;

FIG. 6 illustrates an exploded view of a delivery device according tothe present invention;

FIG. 7 illustrates an embodiment of a coupling system according to thepresent invention;

FIG. 8A illustrates an embodiment of a closure device being partiallydeployed in an internal tissue opening;

FIG. 8B illustrates an embodiment of a delivery device in an orientationcorresponding to the partially deployed closure device of FIG. 8A;

FIG. 9 illustrates an embodiment of a partially deployed closure deviceaccording to the present invention;

FIG. 10A illustrates an embodiment of a closure device positioned in aninternal tissue opening;

FIG. 10B illustrates an embodiment of a delivery device in anorientation corresponding to the deployed and detached closure device ofFIG. 10A;

FIG. 11A illustrates an embodiment of a closure device having aningrowth material according to the present invention; and

FIG. 11B illustrates a side view of the closure device of FIG. 11A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention extends to medical systems, methods, and apparatusfor reducing the size of an internal tissue opening. By way ofexplanation, the devices disclosed herein can be used to treat a varietyof internal tissue openings, such as a left atrial appendage,paravalvular leaks, PDA's, and VSD's, for example. Although, forpurposes of simplicity, frequent reference is made herein to reducingthe size of or closing an opening in heart tissue known as PatentForamen Ovale (“PFO”). Accordingly, it will be understood thatreferences to PFO openings are not limiting of the invention.

In the following description, numerous specific details are set forth toassist in providing an understanding of the present invention. In otherinstances, aspects of delivery and/or closure devices, or medicaldevices in general have not been described in particular detail in orderto avoid unnecessarily obscuring the present invention. In addition, itis understood that the drawings are diagrammatic and schematicrepresentations of certain embodiments of the invention, and are notlimiting of the present invention, nor are they necessarily drawn toscale.

Introduction of Medical System 100

FIG. 2 is a perspective view of a medical system 100 configured tofacilitate closure of an internal tissue opening according to oneembodiment of the present invention. In the illustrated embodiment, themedical system 100 comprises a closure device 200 adapted to reduce thesize of the internal tissue opening, and a delivery device 300 adaptedto facilitate placement and deployment of the closure device 200 withrespect to the internal tissue opening. The medical system 100 of thepresent invention can provide benefits. For example, the medical system100 can be configured to be used with different sizes, shapes and typesof internal tissue openings. Furthermore, the medical system 100 canprovide various safety measures to increase the safety and effectivenessof positioning the closure device 200. In addition, the medical system100 can be configured to provide distributed lateral force to tissue ofthe internal tissue opening.

In the illustrated embodiment, delivery device 300 comprises a handlebody 302, an actuating assembly 320 operatively associated with handlebody 302, a release assembly 340 operatively associated with the handlebody 302 and a delivery assembly 360 operatively associated with theactuating assembly 320, the release assembly 340 and the handle body302. Handle body 302 can be configured to provide a gripping surface fora user. Handle body 302 can be used to position closure device 200, aswell as facilitate deployment of the closure device 200 from thedelivery assembly 360. Actuating assembly 320 can be moved with respectto handle body 302 to selectively deploy portions of the closure device200 from the delivery assembly 360, as will be discussed more fullyherein below.

Release assembly 340 can be operatively associated with the handle body302 to enable selective detachment of closure device 200 from thedelivery assembly 360. Delivery assembly 360 can house closure device200 in a non-deployed or constrained orientation, such as illustrated inFIG. 3B for example, and facilitate deployment of closure device 200.Delivery assembly 360 can include one or more tethers 364 linked to theclosure device 200 to facilitate selective detachment of the closuredevice 200 from the delivery device 300.

Closure Device 200

With reference to FIG. 3A, the closure device 200 is illustrated in afully deployed, expanded, relaxed or non-constrained orientation.According to one embodiment of the invention, the closure device 200 canbe configured to reduce the size of an internal tissue opening so as toclose the internal tissue opening. In one embodiment, the closure device200 can reduce the size of an internal tissue opening by approximating,or in other words bringing together tissue of the internal tissueopening, such as tunnel tissue in a PFO. The closure device 200 canapproximate tissue by applying lateral force to tissue of the internaltissue opening, as will be discussed more fully herein after. Also, theclosure device 200 can be configured to enable a user to estimate theposition and/or orientation of the closure device 200 with respect to aninternal tissue opening, during and after positioning of the closuredevice 200 in the internal tissue opening.

According to one embodiment of the invention, the closure device 200 canbe a non-tubular stent. The closure device 200 can be configured toassume a substantially flat configuration, or in other words beconfigured to be substantially planar, such as illustrated in FIGS. 3Aand 11B for example. Furthermore, the closure device 200 can beconfigured to resist movement out of plane, such as plane 260 of FIG.11B. However, the closure device 200 may bend out of plane whenpositioned in a tissue opening.

The closure device 200 according to one embodiment of the invention hasmany advantages. For example, the closure device 200 can be configuredto be reliable and compliant. The configuration of the closure device200 can enable the closure device 200 to be movable between anon-deployed orientation and a deployed orientation without causingfailure or plastic deformation of the closure device 200. The closuredevice 200 can be used to close various types, shapes and sizes ofinternal tissue openings. Furthermore, the closure device 200 canaccommodate for a range of PFO tunnel lengths, for example. Also, theclosure device 200 can be partially or fully deployed from or receivedback into the delivery device 300. Closure device 200 can be configuredto substantially conform to the size and shape of a tissue opening. Forexample, the undulations on the distal and proximal anchors can enablethe anchors to substantially, or to a certain degree, conform to theanatomy of a tissue opening.

Generally, the closure device 200 can have a substantially flat aspecthaving a length and height greater than its depth or depth thickness.For example, in one embodiment, the closure device 200 has an overalllength of 22 mm, a height of 7.5 mm and a depth thickness of 0.4 mm.According to one embodiment of the present invention, when the closuredevice 200 is in the relaxed or completely expanded orientation, asillustrated in FIG. 3A, the distance between the opposing ends of theproximal anchor 218 can be about 22 mm, the distance between the mostproximal attachment member 240 of the body portion 202 and the mostdistal indicator 220 of the body portion 202 can be about 7.5 mm, andthe depth thickness, designated as DT in FIG. 11B, of the closure device200 can be about 0.4 mm.

Furthermore, the majority of segments comprising the closure device 200can have a thickness or width that is substantially less than the depththickness of the segments. The closure device 200 can resist out ofplane movement due to the size and configuration of the segments. Forexample, the closure device 200 can be configured to assume asubstantially flat configuration in a first plane. The configuration ofthe segments, for example the segments having a certain depth thickness,can facilitate the closure device 200 resisting movement out of thefirst plane in a manner similar to an I beam resisting bending in thedirection of the web of the beam. The first plane can be plane 260 asillustrated in FIG. 11B.

Also, the closure device 200, according to one embodiment of theinvention, can have a unitary construction. For example, the closuredevice 200 can be cut from a single piece of material, such as cut by alaser, thereby removing the need to assemble or join different segmentstogether. A unitary construction can provide advantages, such as ease ofmanufacturing and reliability. For example, assembly is not required fora closure device having a unitary construction. Also, a closure devicehaving a unitary construction may not include distinct elements orsegments which require joining by joints, thereby reducing a likelihoodof failure. The closure device 200 can be made from a super-elasticmaterial, such as a super-elastic metal or a super-elastic polymer.Furthermore, the closure device 200 can be made from NiTiNol, stainlesssteel alloys, magnesium alloys, and polymers including bio-resorbablepolymers.

In some embodiments according to the present invention, the closuredevice can be formed by utilizing a pressurized stream of water, such asa water jet, to remove material from a piece of material to form theclosure device. Furthermore, it is contemplated that the closure devicecan be formed by utilizing one or more of the following: die casting,chemical etching, photolithography, electrical discharge machining, orother manufacturing techniques. It is contemplated that the closuredevice can be formed through use of a mill or some other type of deviceadapted to remove material to form a desired shape.

It will be appreciated by one of ordinary skill in the art in view ofthe disclosure provided herein that the closure device 200 can comprisemultiple segments joined together by a known joining process, such as byan adhesive, by interference fits, crimping, by fasteners, or a weld, orsome combination thereof. For example, in one embodiment, the closuredevice can include multiple segments joined together by various welds toform a closure device according to the present invention. In otherembodiments, the segments can be joined together by a plurality ofmeans, such as by the combination of welding, fasteners, and/oradhesives. The segments can be a wire or multiple joined or rolled wirescrimped together or joined by a joining process to form the closuredevice 200.

In the illustrated embodiment, the closure device 200 includes a bodyportion 202, a first anchor 204 operatively associated with the bodyportion 202 and a second anchor 206 operatively associated with the bodyportion 202. The body portion 202 can be configured to facilitateapplication of lateral force against tissue of an internal tissueopening. Also, the body portion 202 can be configured to enable theclosure device 200 be movable between a non-deployed and deployedorientation. For example, the closure device 200 can be configured to beself-expanding from the constrained or non-deployed orientation, asillustrated in FIG. 3B for example, to the relaxed orientation, asillustrated in FIG. 3A. In other words, the closure device 200 can havea preferential orientation, such that movement of the closure device 200from a first orientation to a second orientation can create internalstresses in the closure device 200. These internal stresses can serve tobias the closure device 200 to the first orientation. For example, inone embodiment, the closure device 200 can have a preferentialorientation of the relaxed or fully deployed orientation as illustratedin FIG. 3A. In this embodiment, movement of the closure device 200 to aconstrained orientation, such as illustrated in FIG. 3B for example, cancreate internal stresses in the closure device 200, thereby creating inthe closure device 200 a bias to return to the relaxed orientation.

In the illustrated embodiment, body portion 202 includes one or morecells 208 defined by a plurality of segments 210. The body portion 202can include one or more apertures. In one embodiment, an aperture isdefined by the cell 208, or in other words by the plurality of segments210. In one embodiment, segment 210 can be a strut or a body supportsegment. Cells 208 can be distinct, or can be at least partially definedby a common segment. For example, cell 208A, as the distal most cell,and cell 208C, as the proximal most cell of body portion 202, aredistinct and defined by distinct segments 210 with respect to eachother. However, cell 208B is partially defined by a segment 210C whichalso defines a portion of cell 208A. Similarly, cell 208B is partiallydefined by a segment 210G which also partially defines cell 208C.Likewise, cell 208D shares a segment 210D with cell 208A and shares asegment 210H with cell 208C.

Segments 210 can be shaped and configured to have a substantiallyuniform stress at any given point along a certain length, when thesegment 210 is deflected. For example, segment 210A can include a firstportion 230 having a width or thickness greater than a second portion232, wherein the width or thickness decreases from the first portion 230to the second portion 232, or in other words is tapered, in a mannerwhich provides for substantially uniform stress levels along the certainlength. In other embodiments, segments can have a substantially constantwidth along their length.

FIG. 3C is a cut-out view of a portion of the closure device 200,including the first portion 230 and the second portion 232 of segment210A. In the illustrated embodiment, the width or thickness of thesegment 210A varies along the portion of the segment 210A from thelocation where segment 210A extends from the portion 254 which joinssegment 210A to segment 210C to the intermediate portion 234. As theclosure device 200 moves between an expanded or otherwise relatedorientation and a constrained or otherwise collapsed orientation, thesegments 210 are deflected, with the highest levels of stress in thesegment 210 being concentrated at the joining portion 254 and decreasingtowards the intermediate portion 234. The segments 210 can be configuredin a manner so as to have a substantially equal stress level along thelength of the segment 210 between the joining portion 254 and theintermediate portion 234. The uniform stress level can be accomplishedby having the width of the segment 210 vary from the first portion 230to the second portion 232 in a calculated manner. In one embodiment, thewidth of the first portion 230 of the segment can be about 0.1 mm andthe taper to a width of about 0.05 mm at the second portion 232 of thesegment.

In other embodiments, the uniform stress level can be accomplished byutilizing a gradient of material having varying properties. In otherembodiments, the segment 210 can have varying widths along its lengthand comprise a gradient of material sufficient to achieve asubstantially uniform stress level between the first portion 230 and thesecond portion 232 of the segment. In the illustrated embodiment, thefirst portion is adjacent the joining portion 254 and the second portionis adjacent the intermediate portion 234. In yet additional embodiments,the joints of the interconnecting segments can include a biasing member,such as a spring, thereby enabling the segments to move relative to eachother to collapse or expand the closure device 200. Furthermore, thebiasing member of the joint can cause the segments to have apreferential orientation with respect to each other.

With continued reference to FIG. 3A, segments 210 can also be configuredto have a rectangular cross-section. In other embodiments, segments 210can have an oval shaped cross section. In yet another embodiment,sections 210 can have a round or rounded cross section. Furthermore, inone embodiment, the ratio, or aspect ratio, of the thickness or width tothe depth thickness of the first and second portions 230, 232 can rangebetween at least about 1:2 to about 1:20. In one embodiment, the aspectratio of the width to the depth thickness of the first portion 230 canbe at least 1:2 and the ratio of the width to the depth thickness of thesecond portion 232 can be at least 1:4. In an alternative embodiment,the aspect ratio of the first portion 230 can be about 1:4 and theaspect ratio of the second portion 232 can be about 1:8. In this manner,the closure device 200 can substantially resist out of plane movement,while allowing in-plane movement during reorientation of variousportions of the closure device 200.

Segments 210 can be configured to be compliant. Compliancy of segments210 can enable cells 208, and thus the body portion 202, to be orientedin various orientations. For example, body portion 202 can be oriented,or in other words moved, between a non-deployed orientation, such asillustrated in FIG. 3B, and a fully deployed orientation, such asillustrated in FIG. 3A. The compliancy of segments 210 can facilitatethe accommodation by the closure device 200 of a variety of types,shapes and sizes of internal tissue openings. For example, the size andconfiguration of the first and second anchors 204, 206 and the bodyportion 202 can enable the closure device 200 to accommodate varyingsizes, shapes and types of internal tissue openings. In oneimplementation, the first anchor 204 can engage wall tissue of aninternal tissue opening and the second anchor 206 can engage only thetunnel tissue of the internal tissue opening to approximate tissue. Inan alternative implementation where the internal tissue opening has ashorter tunnel length, the second anchor 206 can engage the tunneltissue and an opposing wall of the internal tissue opening toapproximate tissue.

Segments 210 can include an intermediate portion 234 configured tofacilitate securement of ingrowth materials to the closure device 200,or can be used as an indicator 220 to facilitate estimation of theposition of the closure device 200 with respect to an internal tissueopening. Furthermore, intermediate portion 234 can be configured tofacilitate measuring of a characteristic of an internal tissue opening.In one embodiment, intermediate portion 234 can include one or moreapertures. The apertures can be configured to receive a securingelement, such as a thread, therethrough to facilitate securing aningrowth material to the closure device 200. Intermediate portion 234can be configured to be stiffer or more rigid than first portion 230,second portion 232, or both. A stiffer intermediate portion 234 canincrease the reliability of segments 210.

In another embodiment, the intermediate portion 234 can include anindicator 220, such as a dense metallic rivet or concentration of densematerial, for use in estimating the orientation and/or position of theclosure device 200. Understanding of the orientation and/or position ofthe closure device 200 can facilitate estimating a physicalcharacteristic of an internal tissue opening and/or the relativeposition of the closure device 200 with respect to the internal tissueopening. For example, if the distance between the indicators 220 isknown, a practitioner can estimate a physical characteristic, such asthe opening or tunnel width, by determining the new distance between theindicators 220 when the closure device 200 is positioned in the tissueopening. Similarly, indicators 220 can be positioned on the first andsecond anchors 04, 206. The indicators 220 can be configured andarranged on the closure device 200 such that when the first anchor 204is deployed the indicators 220 are substantially aligned. In thismanner, a practitioner can estimate whether the first anchor 204 hasfully deployed.

In some cases, it may be difficult to view the closure device 200 in theevent the closure device 200 is at a skewed angle with respect to theviewing plane, such as a fluoroscope. When the closure device 200 isskewed in this manner, it can be difficult to determine accurately thedistance of interest. However, when various distances between indicatorsis known, a user can use the known distances to calculate the distancesof interest by using geometry.

In one embodiment, segments 210 along a similar or common lateral planecan have substantially equal lengths. Substantially equal lengths ofsegments 210 in this manner can enable body portion 202 to be movedbetween the non-deployed and deployed orientation without failure of thesegments 210. For example, in one embodiment, segments 210A and 210Bhave substantially the same length, segments 210E, 210C, 210D, and 210Khave substantially the same length, segments 210F, 210G, 210H and 210Lhave substantially the same length, and segments 210I and 210J havesubstantially the same length. In this configuration, body portion 202can be collapsed or oriented into the non-deployed orientation, asillustrated in FIG. 3B, without causing damage to the body portion 202of closure device.

The closure device 200 can be configured to have a preferentialorientation of the fully deployed orientation as illustrated in FIG. 3A.As the closure device 200 is deployed from the delivery device 300, theconfiguration of closure device 200 can cause the closure device 200 topreferentially move toward the fully deployed orientation. Thus, as theclosure device 200 is deployed in an internal tissue opening, thepreferential orientation of the closure device 200 can cause the closuredevice 200 to apply lateral force to the tissue of the internal tissueopening. In other words, the body portion 202, first anchor 204 and thesecond anchor 206 are deflected by an applied force in order to reorientthe closure device 200 from the fully deployed orientation to anon-deployed orientation, for example. In this manner, the closuredevice 200, because of the deflection of the body portion 202, firstanchor 204 and the second anchor 206, will have tendency to return tothe fully deployed orientation. When the closure device 200 ispositioned in an internal tissue opening, the deflected body portion202, first anchor 204 and the second anchor 206 can have a tendency toapply a lateral force to tissue of the opening as the closure device 200attempts to return to the fully deployed orientation.

Body portion 202 can be operatively associated with the first anchor 204and the second anchor 206. First and second anchors 204, 206 can beconfigured to move between a deployed and non-deployed orientation.First and second anchors 204, 206 can be configured to apply lateralforce to tissue of an internal tissue opening, and to engage and/orcontact a portion of wall tissue and/or tunnel tissue of an internaltissue opening. In one embodiment, the first anchor 204 can be a leftatrial anchor, and the second anchor 206 can be a right atrial anchor.

In the illustrated embodiment, the first anchor 204 can include a firstanchor segment 212 and an opposing second anchor segment 214. Likewise,the second anchor 206 can include a first anchor member 216 and anopposing second anchor member 218. The first anchor segment 212 can beconfigured to move relative to the second anchor segment 214. Likewise,the first anchor member 216 can be configured to move relative to thesecond anchor member 218. In this manner, the closure device 200 canaccommodate for a variety of types, shapes and sizes of internal tissueopenings. The first anchor segment 212 and the second anchor segment 214can be configured to be substantially similar in size, shape andconfiguration. As such, reference to the configuration and/or functionof one of the first or second anchor segments can apply to the otheranchor segment. In one embodiment of the invention, the first anchor 204and/or the second anchor 206 can include one or more undulations. Theundulations can facilitate reorienting or movement of the anchors withrespect to the body portion 202, for example, from a deployed to anon-deployed configuration. Furthermore, the undulations can facilitatethe anchor substantially conforming to the anatomy of the tissueopening.

The first anchor segment 212 can include a distal end 224 and a proximalend 226. The first anchor segment 212 can be defined by various segmentsand can include reinforced segments 228 and one or more engaging members222. For example, in the illustrated embodiment, the first anchorsegment 212 is at least partially defined by segment 210K of cell 208D.The engaging members 222 can be microposts or tines configured tocontact and/or engage tissue. The engaging members 222 can include asharp tip or can be blunt. The engaging members 222 can be configured toprovide a degree of surface texture in order to increase engagement ofthe first anchor 204 with tissue.

The first anchor segment 212 can be configured to be moved between anon-deployed orientation, as illustrated in FIG. 3B, and a fullydeployed orientation, as illustrated in FIG. 3A. The first anchorsegment 212 can be configured such that the distance from the proximalend 226 to the distal end 224 of the segment which includes the engagingmembers 222 is substantially equal to the distance from the proximal end226 to the distal end 224 of the segment which includes the reinforcedsegments 228 and segment 210K. The second anchor segment 214 can beconfigured similar to the first anchor segment 212.

First anchor segment 212 can be configured to define a closed periphery.For example, first anchor segment 212 can include the reinforced segment228 extending from the body portion 202 to the segment having theengaging members 222 which is connected to segments 210K, 210L to definea closed periphery with segment 210K. Furthermore, two reinforcedsegments 228 can extend from the joining portion 254 of the body portion202 and join together near the distal end 224 of the first anchor 204.As such, there are multiple anchor portions extending from the bodyportion 202. In this manner, anchors of the present invention arereinforced to provide greater rigidity and strength to facilitatestabilization and maintenance of the closure device 200 within a tissuestructure.

First anchor member 216 can include a distal end 236 and a proximal end238. The first anchor member 216 can be defined by various segments andcan include one or more engaging members 222. For example, in theillustrated embodiment, the first anchor member 216 is at leastpartially defined by segment 210L of cell 208D. The engaging members 222can be microposts or tines configured to contact and/or engage tissue.The engaging members 222 can include a sharp tip or can be blunt. Theengaging members 222 can be configured to provide a degree of surfacetexture to increase engagement of the second anchor 206 with tissue.

It will be understood by one of ordinary skill in the art in view of thedisclosure provided herein that the engaging members 222 can vary insize and shape, and can be positioned at various locations on theclosure device 200. In alternative embodiments, one or more engagingmembers can extend out of plane of the closure device so as to contacttissue which is perpendicular, for example, to the substantially flatplane, such as plane 260 of FIG. 11B, of the closure device 200.

The first anchor member 216 can be configured to be moved between anon-deployed orientation, as illustrated in FIG. 3B, and a fullydeployed orientation, as illustrated in FIG. 3A. The first anchor member216 can be configured such that the distance from the proximal end 238to the distal end 236 of the segment which includes the engaging members222 is substantially equal to the distance from the proximal end 238 tothe distal end 236 of the segment which includes segment 210L. In thismanner, first anchor member 216 can be detachably coupled to thedelivery device 300 when in a non-deployed orientation inside thedelivery device 300 as illustrated in FIG. 3B. The second anchor member218 can be configured similar to the first anchor member 216.

The first anchor segment 212 can also include a first portion 256 and asecond portion 258 configured to facilitate engagement of the internaltissue opening. For example, first anchor segment 212 can be configuredto include one or more undulations causing the first portion 256 to bepositioned in close proximity with second portion 258. In this manner,as tissue is positioned between the first and second portions 256, 258,the configuration of the first anchor segment 212 can engage, or to somedegree, pinch the tissue therebetween to facilitate maintenance of theposition of the closure device 200 with respect to the tissue opening.

The closure device 200 can also include attachment members 240 for usein detachably linking the closure device 200 to the delivery device 300,as will be discussed more fully herein after. The attachment members 240can include an aperture 242 for use in facilitating the linking of theclosure device 200 to the delivery device 300.

FIG. 3B illustrates the closure device 200 in a non-deployed orconstrained orientation. The configuration of the body portion 202, andthe first and second anchors 204, 206 enables the closure device 200 bereoriented from the fully deployed and preferential orientation, asillustrated in FIG. 3A, to the non-deployed or collapsed orientation asillustrated. In the collapsed or non-deployed orientation, the firstanchor 204 extends distally and the second anchor 206 extendsproximally, with the attachment members 240 being the proximal mostportions of the second anchor 206 and the body portion 202.

In the illustrated embodiment, the closure device 200 is positionedinside of a delivery portion 366 of the delivery device 300. Theconfiguration of the closure device 200 can cause portions of theclosure device to apply force to the wall of the delivery portion 366due to the preferential orientation of the closure device 200. Theclosure device 200 is configured to be received into and deployable fromthe delivery portion 366.

Delivery Device 300

FIG. 4 illustrates one embodiment of the delivery device 300. In theillustrated embodiment, the delivery assembly 360 includes a catheter362 having a delivery portion 366, and a plurality of tethers 364 atleast partially housed by the catheter 362. The tethers 364 can beconfigured to facilitate selective detachment of the closure device 200from the delivery device 300. The delivery portion 366 can be configuredto receive the closure device 200 therein. The catheter 362 can becoupled to the actuating assembly 320, such that movement of theactuating assembly 320 can cause movement of the catheter 362.

In the illustrated embodiment, the actuating assembly 320 includes afirst member 322 operatively associated with the handle body 302, asecond member 324 operatively associated with the first member 322 andthe handle body 302, and a knob 338 linked to the first member 322. Theactuating assembly 320 can be utilized by a user to selectively deploythe closure device 200 from the catheter 362.

The handle body 302 can include indicia 304 to enable a user to estimatethe degree of deployment of the closure device 200 from the deliverydevice 300, as well as predict detachment of the closure device 200 fromthe delivery device 300. For example, indicia 304 can include deploymentindicia 306 and release indicia 308. Deployment indicia 306 can beutilized to enable a user to estimate the degree of deployment of theclosure device 200 from the catheter 362, and the release indicia 308can be utilized to predict the detachment of the closure device 200 fromthe delivery device 300. The handle body 302 can also include a releasepin groove 310. The release pin groove 310 can be operatively associatedwith the release assembly 340 to facilitate the selective detachment ofthe closure device 200 from the tethers 364.

According to one embodiment of the invention, the release assembly 340can include a biasing member 342 operatively associated with the handlebody 302 to facilitate detachment of the closure device 200. A releaseknob 346 can be provided to manipulate the position of biasing member342 in order to release or detach the closure device 200. In oneembodiment, the release knob 346 is coupled to the biasing member 342,such that movement of the release knob 346 can cause movement of thebiasing member 342. The biasing member 342 can include a release pin 344configured to be received in, influenced by and movable in the releasepin groove 310. In this manner, release pin groove 310 can restrict, andthereby influence the movement of the biasing member 342 with respect tothe handle body 302.

The biasing member 342 is configured to interact with the handle body302 such that when the release pin 344 is positioned in a terminatingportion of the release pin groove 310, as illustrated in FIG. 4, thebiasing member 342 is biased in the proximal direction with respect tothe handle body 302. In this manner, the release pin 344 can be movedfrom the terminating portion of the release pin groove 310, asillustrated in FIG. 4, to the opposing terminating portion of therelease pin groove 310 adjacent the release indicia 308B by applyingforce to the biasing member 342 through the release knob 346 in thedistal direction, rotating the release knob 346 and then moving therelease knob 346 in the proximal direction to release the closure device200, as illustrated in FIG. 10B.

FIG. 5A is a cross-sectional view of the distal end of the catheter 362.In the illustrated embodiment, the catheter 362 includes a deliveryportion 366 for use in positioning the catheter 362. The catheter 362can be made from a resilient material having sufficient axial stiffnessto allow a practitioner to position the catheter 362 with respect to aninternal tissue opening, and sufficient rotational stiffness to allow apractitioner to rotate the catheter 362 by rotating the handle body 302.

In one embodiment, the catheter 362 comprises a braided polyimide. Inother embodiments, the catheter 362 can be made from a material having asufficient axial stiffness, such as a braid reinforced polymer, axiallyreinforced polymer, metal reinforced polymer, carbon reinforced polymer,or some other type of axially stiff material. The delivery portion 366can be made from a thermoplastic elastomer, such as PEBAX®. In otherembodiments, the delivery portion or tip portion 366 can be made from amaterial having sufficient flexible properties, such as a polymericmaterial. In other embodiments, the delivery portion 366 can include acombination of materials, such as metallic materials and polymericmaterials.

The delivery portion 366 can define a lumen 368 to facilitate placementof the catheter 362. For example, a guidewire can be received in thelumen 368 to guide the catheter 362 to a desired location. In thismanner, the closure device 200 can be located proximate to the internaltissue opening in a quick and efficient manner. Furthermore, thedelivery portion 366 can be shaped, such as including a bend, in orderto facilitate placement of the delivery portion 366 through a PFO, forexample. In one embodiment of the invention, the catheter 362 can beconsidered a rapid exchange catheter wherein the delivery or tip portion366 enables a guidewire to be linked to the catheter 362 in a quick andefficient manner for placement of the catheter 362.

The catheter 362 and delivery portion 366 can be configured to at leastpartially house tethers 364 in a lumen which is distinct and separatefrom lumen 368. For example, lumen 368 can be in a spaced apart,non-coaxial arrangement from the lumen which houses tethers 364, suchthat a guidewire can be received through lumen 368 without beingintroduced into the lumen or space in which the tethers 364 are housed.In this manner, a user can introduce a guidewire into the lumen 368 atthe distal end of the catheter 362, rather than the lumen which at leastpartially houses the tethers 364 which would require the guidewire to beintroduced into the lumen at the proximal end of the catheter 362. Inalternative embodiments, the lumen 368 configured to receive theguidewire therein can be positioned inside the lumen which houses thetethers 364. In this embodiment, lumen 368 would include an opening andan exit at the distal end of the catheter 362 in order to facilitate thequick placement of a guidewire through the lumen 368.

In one embodiment, catheter 362 can include a rounded cross-section andthe delivery portion 366 can include a rectangular cross-section. Therectangular cross-section of the delivery portion 366 can facilitateproper deployment of the closure device 200 from the delivery device300, as well as facilitate the closure device 200 being reintroducedback into the delivery portion 366. The rectangular cross-section of thedelivery portion 366 can be sized to orient the tethers 364 next to eachother in a linear fashion. In this manner, the likelihood that thetethers 364 cross each other upon reintroduction of the closure device200 into the delivery portion 366 can be reduced.

In one embodiment of the invention, tethers 364 includes three tethers364A-C, each tether 364 being sized and configured to attach to and/oraccommodate therein an attachment member 240 of the closure device 200.One example of a tether is a line or hollow tube coupled to the handlebody 302. The tether 364 can comprise a flexible, hollow shaft havingsufficient stiffness such that as actuating assembly 320 moves thecatheter 362 proximally with respect to the handle body 302, the closuredevice 200 is forced out of the delivery portion 366. Likewise, thetether 364 can be configured to pull the closure device 200 back intothe delivery portion 366 as the actuating assembly 320 is moved distallywith respect to the handle body 302.

In one embodiment, the tether 364 can be a coil of stainless steelcovered by a heatshrunk tubing to give the coil a degree of tensilestrength and rigidity. In an alternative embodiment, the tether 364 canbe a polymeric tube. In yet an additional embodiment, the tether 364 canbe a combination of polymeric materials and metallic materials. In someembodiments, an additional heatshrunk tubing covers a proximal segmentof the three tethers 364A-C. The heatshrunk covering can increase thecolumn strength of the tether 364, which can enable the tethers 364 toassist with deployment and reintroduction of the closure device 200 fromand into the delivery portion 366. The tethers 364 can have a distal tipconfigured to correspond to the shape and size of the attachment members240 of the closure device, such that the attachment member 240 can bereceived into the distal tip of the tether 364, as illustrated in FIG.7.

Tethers 364 can be made from a material having sufficient flexibility tosubstantially prevent distortion or otherwise influence the orientationof the closure device 200 when the closure device is deployed from thecatheter 362, yet have sufficient axial strength to facilitatedeployment of the closure device 200 when the catheter 362 is movedproximally with respect to the closure device 200. The tethers 364 canhave a lumen extending therethrough of sufficient size and configurationto enable a plurality of wires 378 to be housed and movable therein.

FIGS. 5B-5C are cross-sectional views illustrating the delivery assembly360 in association with the actuating assembly 320. However, forsimplicity, FIG. 5B does not include the biasing member 342 andassociated release knob 346, and FIG. 5C illustrates details about theinteraction between the delivery assembly 360 and the actuating assembly320 without illustrating the first member 322 and details about thehandle body 302 and the second member 324. In the illustratedembodiment, the proximal end of the catheter 362 is coupled to thedistal end of the second member 324. In this manner, movement of thesecond member 324 can cause a corresponding movement in the catheter362. For example, as the second member 324 moves proximally with respectto the handle body 302, so also does the catheter 362 move proximallywith respect to the handle body 302.

According to one embodiment of the invention, the tethers 364 can extendfrom the delivery portion 366, through the catheter 362 and the secondmember 324 and are coupled to the handle body 302. The tethers 364 canbe coupled to the handle body 302 by, for example, an intermediatemember 376. The tethers 364 can be covered with a first and secondhousing 370, 372 to provide a degree of rigidity to the portions of thetethers 364 located inside of the handle body 302 and the second member324. For example, in one embodiment, the first housing 370 comprises arigid, hollow, metal rod configured to house the three tethers 364A-Ctherein. The first housing 370 can extend from the intermediate member376, which facilitates securement of the tethers 364 to the handle body302, and terminate at some point beyond the handle body 302.

In the illustrated embodiment, the second housing 372 can extend fromthe distal end of the first housing 370 and extend into the catheter362. The second housing 372 can comprise a resilient material configuredto resist axial stretching while allowing a degree of bending. In oneembodiment, the second housing 372 comprises a coil of metal, such asstainless steel, configured to resist axial stretching, yet allow adegree of bending. The second housing 372 can allow a practitioner tobend a portion of the catheter 362, if needed, in order to manipulatedelivery device 300 for placement of the closure device 200. A seal 374can be provided between the first housing 372 and the second member 324in order to reduce or substantially prevent bodily fluid, which may haveentered the catheter 362, from entering the handle body 302 or otherwiseinappropriately being expelled from the delivery device 300.

In the illustrated embodiment, the second member 324 can comprise anelongate shaft defining an axial lumen 348 and a lumen 350 in fluidcommunication therewith. Lumen 350 can be configured to couple to amedical device for removal of fluid from the delivery device 300. Theaxial lumen 348 can be sized to accommodate and allow movement of thetethers 362, the first housing 370 and the second housing 372 therein.The second member 324 can include a guide 326. The guide 326 can beconfigured to cooperate with a first pin 352 and a second pin 354 toinfluence movement of the second member 324 with respect to the handlebody 302, as will be discussed more fully herein below.

In the illustrated embodiment, the first member 322 comprises a hollowelongate tube sized and configured to enable the second member 324 to bereceived into and moveable within the first member 322. The first member322 can be operatively associated with the handle body 302 and thesecond member 324 to facilitate deployment of the closure device 200.For example, the first member 322 is linked to the handle body 302 by athird pin 356. The third pin 356 is received in a guide 358 of the firstmember 322. The guide 358 is configured to interact with the third pin356 in order to influence the movement of the first member 322 withrespect to the handle body 302.

The first pin 352 can link the first member 322 to the second member324. When the first pin 352 links the first member 322 to the secondmember 324, the second pin 354 links the handle body 302 to the secondmember 324, and the third pin 356 links the handle body 302 to thesecond member 322, movement of the first member 322 can selectivelydeploy the closure device 200 from the delivery portion 366.

With reference to FIGS. 5A-C and 6, the association between the firstmember 322, the second member 324, the handle body 302 and the biasingmember 342 will be discussed. FIG. 6 is an exploded view of theactuating assembly 320 and the release assembly 340. In the illustratedembodiment, the second member 324 is received into the first member 322,and the first member 322 is received into the knob 338 and the handlebody 302, as illustrated in FIGS. 4 and 5B-5C.

According to one embodiment of the invention, the second member 324 caninclude a guide 326 having a first portion 326 a and a second portion326 b, which guide 326 can be defined by a slot formed on the outersurface of the second member 324. In the illustrated embodiment, thefirst portion 326 a is straight and extends along at least a portion ofthe length of the first member 324 and joins with the second portion 326b of the guide 326. The second portion 326 b can include a helicalgroove or slot that begins with and is contiguous with the first portion326 a and extends distally therefrom.

The guide 326 of the second member 324 is configured to interact withthe handle body 302 and the first member 322 to selectively retract thecatheter 362 in order to deploy the closure device 200. For example, thefirst portion 326 a of the guide 326 is configured to interact with thesecond pin 354, which is secured into the handle body 302 by means ofthreads and extend into the first portion 326 a of the guide 326. Inthis manner, the second member 324 can move laterally with respect tothe handle body 302. Thus, rotation of the handle body 302 can translateto rotation of the second member 324, and thus, the catheter 362 and thedelivery portion 366.

The second portion 326 b of the guide 326 is configured to interact withthe first pin 352, which is secured to the first member 322 by means ofthreads and extends into the second portion 326 b of the guide 326. Inthis manner, as the first member 322 is rotated, the first pin 352 willinteract with the second portion 326 b to move the second member 324 inthe proximal direction. As the second member 324 is moved in theproximal direction with respect to the handle body 302, the catheter 362moves proximally with respect to the handle body 302 thereby exposing ordeploying the closure device 200 from the delivery portion 366.

In the illustrated embodiment, the first member 322 can include a guide358 defined by a slot or groove formed in the outer surface of the firstmember 322. In the illustrated embodiment, the guide 358 can include afirst portion 358 a connected to a second portion 358 b. The firstportion 358 a of guide 358 can be straight and extend along at least aportion of the length of the first member 322, and then join and becontiguous with the second portion 358 b. The second portion 358 b ofthe guide 358 can be a helical groove that wraps around at least aportion of the outer surface of the first member 322 and extends alongat least a portion of the length of the first member 322.

As described previously, the third pin 356, which is secured to thehandle body 302 by means of threads, can extend into the guide 358 inorder to influence movement of the first member 322 with respect to thehandle body 302. For example, as the third pin 356 is positioned in themost proximal portion of the first portion 358 a, the closure device 200is completely received into and enclosed by the delivery portion 366. Asthe first member 322 is moved in the proximal direction as illustratedby the arrow in FIG. 4, the third pin 356 moves in the first portion 358a of the guide 358 to deploy the first anchor 204 of the closure device200 from the delivery portion 366.

The length of the first portion 358 a can correspond with the distancethat the first member 322, and thus the catheter 362, must move in orderto deploy the first anchor 204 of the closure device 200 from thedelivery portion 366. For example, a practitioner can move the knob 338,which is coupled to the first member 322, in the proximal direction.Movement of the knob 338 in the proximal direction can cause the thirdpin 356 to move linearly in the first portion 358 a of the guide 358. Inthis manner, the second member 324 can move correspondingly with thefirst member 322 because of the first pin 352, which links the firstmember 322 to the second member 324. As the third pin 356 is positionedin the location of the guide 358 where the first portion 358 a meetswith the second portion 358 b, the first member 322 can be rotated inorder to selectively deploy the remaining portions of the closure device200 from the delivery portion 366 of the delivery device 300.

As the first member 322 is rotated, the third pin 356 is positioned inthe second portion 358 b to influence movement of the first member 322with respect to the handle body 302, and the first pin 352, which iscoupled to the first member 322, interacts with the second portion 326 bof the guide 326 to move the second member 324 in the proximal directionwith respect to the handle body 302. Movement of the second member 324in the proximal direction in this manner can cause further deployment ofthe closure device 200 from the delivery portion 366. As will beappreciated, the knob 338 can be coupled to the first member 322 tofacilitate and enable movement of the first member 322 with respect tothe handle body 302.

The dual movement required to deploy the closure device 200 can providesome efficiency and safety advantages. For example, a practitioner canmove the knob 338 in a first direction (i.e., proximally in a linearfashion) to deploy the first anchor 204 from the delivery portion 366.Thereafter, the practitioner can move the handle body 302 to positionthe first anchor 204 against the wall tissue of an internal tissueopening, such as against the left atrial wall of a heart, for example.Once the first anchor 204 is positioned against the wall, thepractitioner can move the knob 338 in a second direction (i.e., rotatethe knob) to further deploy the closure device 200 from the deliveryportion 366. The dual movement enables a user to predict the deploymentof the closure device 200 to reduce the risk of premature deployment ofthe closure device.

It will be understood by one of ordinary skill in the art in view of thedisclosure provided herein that other means of controlling movement ofone member with respect to the other, such as the first member withrespect to the second member, can be utilized without departing from thescope and spirit of the invention. For example, a structure configuredto substantially restrict or control movement of the first element withrespect to the second element and/or handle body can be utilized. In oneembodiment, the structure can include a cam and a follower. In analternative embodiment, the structure can include a slider.

The release assembly 340 can be configured to be received in theproximal end of the handle body 302. The release assembly 340 can beconfigured to provide additional safety features for the practitionerand patient by reducing the risk of premature detachment of the closuredevice 200 before it is positioned appropriately in an internal tissueopening. For example, a practitioner using the medical system 100 of thepresent invention can manipulate the actuating assembly 320 to deploythe closure device 200 for positioning in an internal tissue opening. Inorder to deploy a first portion of the closure device 200, a user canmove the knob 338, and thus the first member 322, in the proximaldirection with a first movement, which is a linear movement, then deploythe remaining portions of the closure device 200 by a rotationalmovement. Once the closure device 200 is deployed, the practitioner canbe required to move their hands in order to utilize the release assembly340 to release the closure device 200 from the delivery device 300.

In the illustrated embodiment the release assembly 340 can include arelease knob 346 coupled to a biasing member 342, which is received intothe proximal end of the handle body 302. The biasing member 342 can beconfigured to include a plurality of slots 318 configured and arrangedto act similar to a spring. The slots 318 can be configured and arrangedin the biasing member 342 to enable at least a portion of the biasingmember 342 to be compressed. Compression of the biasing member 342 cancause the release pin 344 to move toward the distal end of the biasingmember 342.

The biasing member 342 can be configured such that when biasing member342 is positioned in the handle body 302, the biasing member 342naturally tends to maintain its position with the release pin 344 in therelease pin groove 310 as illustrated in FIG. 4. As force is applied tothe release knob 346 in the distal direction (i.e., compress the biasingmember 342), the release pin 344 can be moved out of a terminatingportion of the release pin groove 310 and rotated and moved into aproximal terminating portion of the release pin groove 310 to releasethe closure device 200 from the delivery device 300.

The closure device 200 is released from the delivery device 300 bymoving a plurality of wires 378 which are housed by a tether 364 andcoupled to the biasing member 342. Illustrated in FIG. 7 is across-sectional view of attachment member 240 of the closure device 200received into a tether 364 and coupled by first and second wires 378 a,378 b. In the illustrated embodiment, a second wire 378 b can extendthrough and out of the tether 364 and form a loop. The loop can extendthrough an aperture 242 of the attachment member 240 of the closuredevice 200. With the loop of second wire 378 b positioned through theaperture 242 of the attachment member 240, a first wire 378 a, whichextends through and out of the tether 364, can extend through the loopof the second wire 378 b to form a locking feature. When the first wire378 a extends sufficiently through the loop of the second wire 378 b,the closure device 200 can remain coupled to the delivery device 300until the first wire 378 a is pulled through the loop of the second wire378 b, and the second wire 378 b is pulled out of the aperture 242 ofthe attachment member 240.

The first wire 378 a and the second wire 378 b can be attached at theirproximal ends to the biasing member 342. In this manner, movement of thebiasing member 342 in the proximal direction can cause movement of thewires 378 also in the proximal direction. In one embodiment, the wires378 can be coupled to the biasing member 342 such that movement of thebiasing member 342 will cause the first wire 378 a to move a distancesufficient to be removed from the loop of second wire 378 b before thesecond wire 378 b is moved by the biasing member 342. The wire 378 cancomprise a metallic wire, such as a NiTiNol wire. The wire 378 can alsoinclude a stainless steel wire or some other type of metal or stiffpolymer. The wires 378 can be made from a material having a sufficienttensile strength to secure the closure device 200 to the tethers 364without causing the wires 378 to fail or substantially deform. In oneembodiment of the invention, the wire 378B can include a stainless stealwire and wire 378A can include a NiTiNol wire.

Other types and configurations of biasing members can be utilizedwithout departing from the scope and spirit of the invention. Forexample, in one embodiment, the release assembly can include a rotatingmember coupled to the securing elements. In this embodiment, rotation ofthe rotating member can cause the securing elements to wind around therotating member thereby causing the distal ends of the securing elementsto move proximally with respect to the handle body.

The method of use of the medical system 100 will now be described withreference to a particular internal tissue opening, namely a PFO. FIG. 8a illustrates the positioning of the catheter 362 through the tunnel 58of a PFO with the first anchor 204 of the closure device 200 deployed.The medical system 100 is utilized to close an internal tissue openingby positioning the catheter 362 through an internal tissue opening andmoving the first member 322 by a first movement (i.e., linearly) in theproximal direction to deploy the first anchor 204 of the closure device200. After the first anchor 204 of the closure device 200 is deployed,the delivery device 300 can be moved in the proximal direction in orderto seat the first anchor 204 against the wall of the tissue opening orotherwise engage the wall of the internal tissue opening, as illustratedin FIG. 9. This can be done by moving the handle body 302 in theproximal direction.

After the first anchor 204 has been positioned against the wall of theinternal tissue opening, the knob 338, and thus the first member 322,can moved by a second movement, or in other words, rotated to deployadditional portions of the closure device 200 as illustrated in FIG. 9.After the closure device 200 has been fully deployed and conforms to theanatomy of the internal tissue opening, the release assembly 340 can beactuated to selectively detach the delivery device 300 from the closuredevice 200 as illustrated in FIGS. 10 a and 10 b.

The release assembly 340 can be actuated by moving the biasing member342 distally with respect to the handle body 302, then rotating thebiasing member with respect to the handle body 302, and then movedproximally with respect to the handle body 302. In this manner, closuredevice 200 substantially conforms to the anatomy of the internal tissueopening. As noted previously, the configuration of the closure device200 is such that when positioned in the internal tissue opening asillustrated, the members of the closure device 200 apply lateral forceto the tissue of the internal tissue opening, such as the tunnel 58 ofthe PFO, to approximate tissue of the PFO for closure.

FIG. 11A illustrates one embodiment of a closure device 200 that caninclude a member 250, such as an ingrowth material. The member 250 canbe configured to induce tissue growth. The member 250 can be fixed tothe closure device 200 by means of a securing element, such as a thread252. For example, the thread 252 can extend through the member 250 andthrough the apertures in the intermediate portions 234 in order tosecure the member 250 to the closure device 200. In other embodiments,the member 250 can be secured to the closure device 220 by a knownsecuring means, such as by an adhesive, a heat weld, or some other knownor hereafter developed means for securement.

The member 250 and the thread 252 can include a bio-resorbable material,such as polylactide or polyglycolide or collagen. The member 250 can besized and configured to enable the closure device 200 to be deployedfrom and received into the delivery portion 366 of the delivery device300. Furthermore, the member 250 can be configured to interact withtissue of the internal tissue opening to stimulate growth of tissue forclosure of the internal tissue opening. For example, the member 250 caninteract with the tunnel tissue 58 of a PFO in order to stimulate growthof tissue in the PFO tunnel 58.

The member 250 can be any suitable material which can or tends topromote tissue growth. Examples of such material can include a polymericmaterial, or a woven material, such as a woven metallic or biologicalmaterial. In one embodiment, the member 250 can be a piece of foam. Inalternative embodiments, the member 250 can be a piece of yarn, fabricor string, or some combination thereof. Other tissue growth promotingmembers can include a coating disposed on the closure device 200. Inother embodiments, the member 250 can be a piece of foam, braidedmaterial such as a piece of yarn or string, or fabric which has acoating disposed thereon.

The member 250 can include materials such as a piece of polyurethane orsome other biocompatible polymer, including bio-resorbable polymers. Themember 250 can also include Dacron or polymeric threaded material whichhave been woven or knitted, or formed into compressed, non-wovenfabrics. The member 250 can also include a metallic material, such as aNiTiNol, stainless steal or some other biocompatible alloy orbio-resorbable metal, such as magnesium alloy, or some combinationthereof. In one embodiment, the member 250 comprises a metallic wire.

FIG. 11B illustrates a side view of the closure device 200, andillustrates one example of the closure device having a substantiallyflat configuration. In the illustrated embodiment, the closure device200 can include a depth or depth thickness designated as DT, and a plane260 extending perpendicular into and out of the plane of the page. Inthis embodiment, the member 250 can extend beyond at least a first edge262 of the closure device 200. Furthermore, the member 250 can extendbeyond both the first edge 262 and a second edge 264 of the closuredevice 200. In this manner, member 250 can contact tissue adjacent theclosure device 200 to promote tissue growth in the tissue opening.

The member 250 can be sized and configured to extend beyond at least thefirst edge 262 of the closure device 200 a sufficient distance tocontact tissue of the tissue opening. In one embodiment, the member 250can extend beyond at least the first edge 262 a sufficient distance tocontact tissue adjacent the first edge 262, thereby causing the end ofthe member 250 which is in contact with the tissue to deflect or bend.In this manner, more surface area of the member 250 can be in contactwith tissue to thereby facilitate an increase in tissue growth. In otherembodiments, the member 250 can extend beyond both the first edge 262and the second edge 264 a sufficient distance to cause both ends of themember 250 to bend, which can result in more surface area contacting thetissue. In one embodiment, the member 250 can extend between at least0.5 mm and 5 mm beyond the first edge 262. In another embodiment, themember 250 can extend between at least 0.5 mm and 5 mm beyond the firstedge 262, and can extend between at least 0.5 mm and 5 mm beyond thesecond edge 264. Furthermore, the member 250 can have a thickness ofbetween at least 0.25 mm and 2 mm.

In addition, in some embodiments the member 250 can be configured todecrease the size of a remaining void in the tissue opening after theclosure device 200 has been positioned in the tissue opening. Member 250extending beyond the first edge 262 of the closure device 200 is anexample of the member 250 extending substantially out of plane of thesubstantially flat configuration.

The present invention can also include the following methods, systemsand devices.

A medical device comprising: a body portion comprising two or morecells, said body portion being movable between a deployed andnon-deployed orientation; and at least one anchor linked to said bodyportion, said at least one anchor being adapted to reduce proximalmovement of the medical device when the medical device is positioned inan internal tissue opening.

A medical device comprising: a multi-cellular structure adapted toselectively expand and contract between a deployed and non-deployedorientation; a first anchor operatively associated with saidmulti-cellular structure, said first anchor being adapted to selectivelyengage at least a portion of a wall of an internal tissue opening; and asecond anchor operatively associated with said multi-cellular structure,said second anchor being adapted to engage at least a portion of atleast another portion of the wall of the tissue opening.

A method for closing a Patent Foramen Ovale, comprising the steps of:positioning at least a portion of a medical device into a left atrium ofa heart, said medical device comprising a first anchor, a multi-cellularstructure linked to said first anchor, and a second anchor linked tosaid multi-cellular structure, said first anchor, said multi-cellularstructure and said second anchor being adapted to selectively movebetween a non-deployed and deployed orientation; locating at least aportion of said first anchor against at least a portion of a left atrialwall of the heart; and locating at least a portion of said second anchoragainst at least a portion of at least one of a tunnel of the PatentForamen Ovale or a right atrial wall of the heart.

A medical device for approximating tissue of an internal tissue openingtogether, the medical device comprising: a body portion comprising twoor more cells, said body portion being adapted to apply lateral force totissue of an internal tissue opening; and at least one anchoroperatively associated with said body portion.

A medical device for approximating tissue of an internal tissue openingtogether, the medical device comprising: a multi-cellular structureadapted to selectively expand and contract between a deployed andnon-deployed orientation, said multi-cellular structure configured topreferentially expand; and at least one anchor operatively associatedwith said multi-cellular structure, said at least one anchor beingadapted to move between a deployed and non-deployed orientation, atleast a portion of said at least one anchor being adapted to applylateral force to at least a portion of tissue of an internal tissueopening when said first anchor is deployed.

A method for reducing the size of an internal tissue opening, comprisingthe steps of: positioning at least a portion of a medical device throughan internal tissue opening, said medical device comprising amulti-cellular structure and at least a first anchor associated withsaid multi-cellular structure, said at least one anchor and saidmulti-cellular structure being adapted to selectively move between anon-deployed and deployed orientation; and applying lateral force totissue of the internal tissue opening by at least partially deployingsaid at least one anchor.

A medical device comprising: two or more cells forming a body portion,said body portion being adapted to move between a collapsed and expandedorientation to apply lateral force to tissue of an internal tissueopening; and at least one anchor linked to said body portion, said atleast one anchor being adapted to extend distally when said at least oneanchor is collapsed and extend laterally when said at least one anchoris moved from a collapsed to an expanded orientation.

A method for deploying a closure device, the method comprising the stepsof deploying a left anchor of a closure device from a delivery device,said delivery device comprising an actuating assembly operativelyassociated with a handle body, said left anchor being adapted to deployby linearly moving at least a portion of said actuating assembly withrespect to said handle body; and deploying a second anchor of saidclosure device from said delivery device by rotating at least a portionof said actuating assembly with respect to said handle body.

A delivery device for an internal tissue opening closure device, thedelivery device comprising: a handle body including first and secondguide members; a first member operatively associated with said handlebody, at least a portion of said first member defining a guide, saidfirst guide member cooperating with said guide to influence movement ofsaid first member with respect to said handle body, said first memberincluding a guide structure; and a second member operatively associatedwith said first member, at least a portion of said second memberdefining a second guide, said guide structure cooperating with saidsecond guide to influence the movement of said second member withrespect to said first member, and said second guide member cooperatingwith said second guide to influence the movement of said second memberwith respect to said handle body.

A delivery device for an internal tissue opening closure device, thedelivery device comprising: a handle body; a first pin coupled to saidhandle body; a second pin coupled to said handle body; a first camadapted to be at least partially received into and movable with respectto at least a portion of said handle body, said first cam including aslot formed on an external surface of said first cam, said slotincluding a first portion and a second portion, said first portion ofsaid slot extending along at least a portion of the length of said firstcam, said second portion of said slot extending at least partiallyaround said first cam, said first pin received in said slot; a third pincoupled to said first cam; and a second cam adapted to be at leastpartially received into and movable with respect to at least a portionof said first cam, said second cam including a first and second slotformed on an external surface of said second cam, said first slot ofsaid second cam extending at least partially around said second cam andsaid second slot of said second cam extending along at least a portionof the length of said second cam, said third pin received in said firstslot of said second cam and said second pin received in said second slotof said second cam.

A medical device for closing an internal tissue opening, the medicaldevice comprising: a multi-cellular structure configured to assume asubstantially flat configuration; at least one anchor operativelyassociated with said multi-cellular structure, said at least one anchorcomprising a plurality of segments at least partially defining a closedperiphery.

A medical device for closing an internal tissue opening, the medicaldevice comprising: a multi-cellular structure adapted to be moveablebetween a first orientation and a second orientation; at least oneanchor operably associated with said multi-cellular structure; and atissue growth member associated with said multi-cellular structure, saidtissue growth member being adapted to enhance tissue growth in theinternal tissue opening.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. An expandable medical device deployable at leastpartially within a tissue structure and adjacent a left atrium of aheart, the expandable medical device comprising: a frame comprising amulti-cellular central frame portion and at least one anchor, the frameconfigured to self expand from a first, non-tubular orientation to asecond, non-tubular orientation while maintaining a substantially flatconfiguration, the first orientation being substantially similar to acollapsed orientation within a catheter, the second orientation beingsubstantially similar to an orientation wherein the central frameportion is deployed and operable substantially within the tissuestructure and adjacent the left atrium, said central frame portioncomprising a plurality of interconnecting central frame support strutsdefining at least two cells, at least one of said central frame supportstruts having a length and a width, the width varying at least partiallyalong the length in a tapered configuration, said at least one anchorlinked to said multi-cellular central frame portion and configured toextend in the left atrium; wherein said plurality of interconnectingcentral frame support struts each include an arcuate portion extendingalong the length thereof, and each of said at least two cells of saidmulti-cellular central frame portion is defined by at least four of saidplurality of interconnecting central frame support struts in a closedcell configuration such that each cell includes a common frame supportstrut of an adjacent cell.
 2. A medical device as recited in claim 1,wherein said central frame portion comprises three or more cells.
 3. Amedical device as recited in claim 1, wherein said central frame portionis configured to apply lateral force to tissue of the tissue structure.4. A medical device as recited in claim 1, wherein said at least oneanchor comprises a distal anchor including a plurality of anchor framesegments extending from the central frame portion, wherein at least twoof the anchor frame segments extend substantially parallel to each otheralong at least a portion of their respective lengths.
 5. A medicaldevice as recited in claim 1, further comprising at least a secondanchor operatively associated with said central frame portion.
 6. Amedical device as recited in claim 1, further comprising a tissue growthmember coupled to said central frame support struts, wherein said tissuegrowth member is configured to induce tissue growth, said tissue growthmember being independently bendable relative to the central framesupport struts of the frame as the tissue growth member contacts tissuein the hole of the tissue structure.
 7. An expandable medical devicedeployable at least partially within a hole defined in a tissuestructure between a left atrium and a right atrium of a heart, the holedefining an axis oriented axially through the hole, the expandablemedical device comprising: a frame configured to maintain asubstantially flat configuration as said frame transitions andself-expands from a non-deployed state to an intended, as deployedstate, the frame being in a non-tubular orientation in the intended, asdeployed state, said frame oriented substantially parallel to, orextending substantially along, the axis of the hole when in saidintended, as-deployed state within the tissue structure, said framecomprising a central portion, at least one proximal anchor and at leastone distal anchor, said central portion comprising a plurality of strutsdefining a multi-cellular structure, said at least one proximal anchorand said at least one distal anchor each configured to extendsubstantially coplanar with said central portion, and said at least onedistal anchor configured to extend in the left atrium and said at leastone proximal anchor configured to extend in the right atrium; and atissue growth member coupled to the plurality of struts of the frame andconfigured to induce tissue growth within the hole of the tissuestructure, the tissue growth member being independently bendablerelative to the plurality of struts of the frame as the tissue growthmember contacts tissue in the hole of the tissue structure; wherein saidplurality of struts each include an arcuate portion extending along alength thereof, and each cell of said multi-cellular structure isdefined by at least four of said plurality of struts in a closed cellconfiguration such that each cell includes a common strut of an adjacentcell.
 8. A medical device as recited in claim 7, wherein said framecomprises a superelastic material.
 9. A medical device as recited inclaim 7, wherein said frame is configured to assume said substantiallyflat configuration lying in a first plane, said frame being configuredto resist movement out of said first plane of the substantially flatconfiguration.
 10. A medical device as recited in claim 7, wherein saidcentral portion is configured to preferentially expand to the intended,as deployed state.
 11. A medical device as recited in claim 7, whereinsaid at least one distal anchor is operatively associated with a distalportion of said central portion.
 12. A medical device as recited inclaim 11, wherein said at least one distal anchor is configured toreduce proximal movement of the medical device when the medical deviceis positioned in the tissue structure.
 13. A medical device for reducinga size of a Patent Foramen Ovale (“PFO”) defined in a septum wallbetween a left atrium and a right atrium of a heart, the PFO defining anaxis oriented axially through the PFO, the medical device comprising: aself-expanding frame configured to maintain a substantially flatconfiguration as said frame transitions from being constricted within acatheter to being deployed from the catheter, said frame configured toassume an expanded, substantially flat configuration orientedsubstantially parallel to, or extending substantially along, the axis ofthe PFO when positioned within the PFO, the frame being in a non-tubularorientation upon the frame assuming the expanded, substantially flatconfiguration, said frame comprising a central portion with proximal anddistal anchors extending from said central portion, at least one of saidproximal anchors and at least one of said distal anchors configured toextend substantially coplanar with said central portion, said centralportion comprising a plurality of struts defining a multi-cellularstructure configured to self-expand outwardly against a wall of the PFO,at least one of said proximal anchors configured to extend in the rightatrium and at least one of said distal anchors configured to extend inthe left atrium; and a tissue growth member having an elongatedstructure, the tissue growth member coupled to the plurality of strutsof the frame and configured to induce tissue growth within the PFO, thetissue growth member being independently bendable relative to theplurality of struts of the frame as the tissue growth member contactstissue within the PFO; wherein said plurality of struts each include anarcuate portion extending along a length thereof, and each cell of saidmulti-cellular structure is defined by at least four of said pluralityof struts in a closed cell configuration such that each cell includes acommon strut of an adjacent cell.
 14. A medical device as recited inclaim 13, wherein said frame comprises a flat stent.
 15. A medicaldevice as recited in claim 13, wherein at least one of said proximalanchors is linked to said central portion.
 16. A medical device asrecited in claim 13, wherein at least one of said proximal anchors isadapted to engage at least a portion of a tunnel of the PFO and theright atrial wall of a heart.
 17. A medical device as recited in claim16, wherein at least one of said distal anchors is adapted to engage atleast a portion the tunnel of the PFO.
 18. A medical device as recitedin claim 13, wherein at least one of said proximal or distal anchorscomprises one or more engaging members.
 19. A medical device forreducing the size of an internal tissue opening defined in a tissuestructure between a left atrium and a right atrium of a heart, theopening defining an axis oriented axially through the opening, themedical device comprising: a frame including a central portion having aplurality of struts defining a multi-cellular structure configured to bepositioned substantially within the tissue structure when in anintended, as deployed state, said central portion having at least adistal anchor and a proximal anchor each extending from said centralportion, said frame configured to maintain a substantially flatconfiguration as said frame transitions and self-expands from anon-deployed state to said intended, as deployed state, said frame beingin a non-tubular orientation in said intended, as deployed state, andsaid distal anchor and said proximal anchor each extending substantiallycoplanar with the central portion, said distal anchor configured toextend in the left atrium and said proximal anchor configured to extendin the right atrium, said substantially flat configuration configured tobe oriented substantially parallel to, or extend substantially along,the axis of the opening; and a member associated with said frame, saidmember adapted to induce tissue growth in the internal tissue opening,said member being independently bendable relative to said frame uponcontacting tissue in the internal tissue opening; wherein said pluralityof struts each include an arcuate portion extending along a lengththereof, and each cell of said multi-cellular structure is defined by atleast four of said plurality of struts in a closed cell configurationsuch that each cell includes a common strut of an adjacent cell.
 20. Amedical device as recited in claim 19, wherein said central portion isconfigured to preferentially expand.
 21. A medical device as recited inclaim 19, wherein said member comprises an ingrowth member.
 22. Amedical device as recited in claim 19, wherein said member is secured tosaid central portion by a securement member.
 23. A medical device asrecited in claim 19, wherein said member is associated with said framethrough an adhesive.
 24. A medical device as recited in claim 19,wherein said member is configured to substantially extend out from saidcentral portion.
 25. A medical device as recited in claim 19, whereinsaid member comprises at least one of polylactide or polyglycolide orcollagen.
 26. A medical device as recited in claim 19, wherein saidmember comprises a bio-resorbable material.
 27. A medical device asrecited in claim 19, wherein the member comprises a polymeric material.28. A medical device as recited in claim 19, wherein the membercomprises foam.
 29. A medical device for closing an internal tissueopening defined in a tissue structure between a first atrium and asecond atrium of a heart, the opening defining an axis oriented axiallythrough the opening, the medical device comprising: a frame including acentral portion having a plurality of support segments defining amulti-cellular structure and with at least a first anchor and a secondanchor each extending from said central portion, said central portionconfigured to be positioned substantially within the tissue structurewhen in an intended, as deployed state, and said first anchor configuredto be positioned in the first atrium when in the intended, as deployedstate, and said second anchor configured to be positioned in the secondatrium when in the intended, as deployed state, said frame configured tomaintain a substantially flat configuration as said frame transitionsand self-expands from a non-deployed state to the intended, as deployedstate, said frame being in a non-tubular orientation in the intended, asdeployed state, said frame configured to be oriented substantiallyparallel to, or extending substantially along, the axis of the openingupon delivery to the internal tissue opening in the intended, asdeployed state, said first anchor and said second anchor extendingsubstantially coplanar with said central portion; and a porous tissuegrowth promoting member attached to said frame, said tissue growthpromoting member having an elongated structure configured to be orientedtransverse to the axis of the hole and configured to be oriented acrossa width of the hole, said elongated structure having a height dimensionconfigured to substantially extend out-of-plane at least 0.5 mm from thesubstantially flat configuration and configured to be positioned withinthe internal tissue opening to enhance tissue growth therein; whereinsaid plurality of support segments each include an arcuate portionextending along a length thereof, and each cell of said multi-cellularstructure is defined by at least four of said plurality of supportsegments in a closed cell configuration such that each cell includes acommon support segment of an adjacent cell.
 30. A medical device asrecited in claim 29, wherein said frame comprises a flat stent.
 31. Amedical device as recited in claim 29, wherein said tissue growthpromoting member comprises an ingrowth material.
 32. A medical device asrecited in claim 29, wherein said tissue growth promoting member issecured to said frame by a securing means.
 33. A medical device asrecited in claim 32, wherein said securing means includes at least oneof a securement member or an adhesive.
 34. A medical device as recitedin claim 29, wherein said tissue growth promoting member comprises abio-resorbable material.
 35. A medical device as recited in claim 29,wherein the tissue growth promoting member comprises a polymericmaterial.
 36. A medical device as recited in claim 29, wherein thetissue growth promoting member comprises foam.